This is what you will do:In Alexion Technical Operations (ATO), we work closely with Alexion's manufacturing network of internal sites and external manufacturing partners, our colleagues in Development, Quality, Regulatory, Supply Chain, and Commercial Operations to provide technical leadership to ensure delivery of quality products to our patients and support our product pipeline.
The Product Technical Lead (PTL) is responsible for providing company-wide technical leadership of Alexion's commercial products throughout the product lifecycle.
As the technical product expert, the incumbent will build and implement strategy to proactively minimize technical risks, through early detection and mitigation of same during technology transfer activities, and commercial operations.
The PTL is the technical liaison within Alexion Technical Operations, working with, Site Technical Services, Regulatory Affairs, Operations, Quality Assurance, Quality Control, Process Development, and other functions to ensure regulatory compliance, best in class technical manufacturing, and associated testing processes.The role bridges efficient communication and decision making related to the technical quality of our products, including the identification and mitigation of risk, and supporting continual technical improvement initiatives across the sites manufacturing our products.You will be responsible for:Be the company-wide technical lead for assigned (bio)pharmaceutical product(s) of the portfolio encompassing a variety of modalities, primarily drug substance, raw materials through drug product packaging and associated testing of manufactured productsMaintain knowledge and history of the product(s) process throughout the entire commercial lifecycle, inclusive of development history Perform process management in the following areas (but not limited to):Owner of product improvement road mapOwner of specification review committeesOwner of product technical risk summary (based on product risk register) in conjunction with product quality risk registerPerform process capability analysis (periodic basis) and provide recommendations, in support of APQRs and product reviewsReview CPV plans and outputs reports for recommendationsServe as an empowered Alexion Technical Operations representative working collaboratively and cross-functionally with Strategic Product Leads and team members contributing to product vision, strategy, plans, and delivery - must consult with functional leaders and bring Operations view to the table to support decision-making and planningSupport Operations by providing technical expertise for investigation and resolution of process deviations with internal/external manufacturing, through authoring/ review and mentoring on key risk assessmentsProactively manage risk and drive product related decisions to ensure the Product team is successful in achieving improvement goalsIdentify and lead through to approval, opportunities for process/operational improvements that can be replicated and implemented across the manufacturing networkCollaborate with Technical Services (internal/external) to design, implement and maintain robust process control strategies for products during Technology Transfer and commercial manufacture stages.
Author, review and approve CMC sections of regulatory agency submissions, responses (IRs), supporting successful regulatory agency inspections by providing subject-matter expertise on technology transfer, and process, to support the technical content of filings and ensuring flexibilities are built in to minimize impact of future process changesServe as the empowered Operations representative on CMC Product teams for late-stage clinical products to ensure delivery of commercial products that are consistent with Operations long term strategiesYou will present/defend technical and scientific approaches in both written and verbal form, including during regulatory agency inspections Define, implement, and improve business processes for technical aspects of product lifecycle managementDefine the methodology and approaches for developing business cases for lifecycle improvement projects, considering technical, financial, supply and regulatory aspectsEmbed Digital solutions into PTL related workflows that enables reduction in NVACapture and embed lessons learned from commercial experience back into late stage filing approach, reducing technical risks for continued commercial supply and on time approvalsYou will need to have:Degree in scientific or engineering subject area with experience in (bio)pharmaceutical manufacturing/development/process engineering:Minimum Batchelors DegreeDemonstrated previous experience in a CMC lead / product technical lead role with demonstrated ability to lead cross functional team in a matrix environmentDemonstrated ability to build new organisations or business processesExtensive technical knowledge of pharmaceutical manufacturing, in Technical, R&D, Process Development, or similar Product Stewardship/Champion roles.
Experience in a combination of areas such as DS/DP processes, combination devices, final packaging, vaccine manufacture, cell and gene therapy, oligonucleotides, and associated relevant background in analytical testing/characterisationExtensive technical knowledge of commercial manufacturing with experience with biologics or small molecule, or development manufactureComprehensive understanding of cGMP requirements and the ability to implement best practices to ensure technical excellenceExpertise in successful execution and management of technology transfer, process support within a clinical/commercial facility, or product development settingExcellent communication skills with the ability to successfully influence across levels, across functions, with senior leaders and technical leadersAbility to work in a complex, dynamic, global environment, thinking strategically and balancing both long and short-term prioritiesStrong technical writing skills and statistical analysis experienceAbility to travel up to 15%The duties of this role are generally conducted in an office environment.
As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video and electronic messaging; engage in problem solving and non-linear thought, analysis and dialogue; collaborate with others, maintain general availability during standard business hours We would prefer for you to have:Masters / advanced degree preferred Experience of statistical analysis, and software packages (e.g., JMP)Strong level of proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPointDate Posted06-Sep-2024Closing Date19-Sep-2024Our mission is to build an inclusive and equitable environment.
We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process.
We welcome and consider applications from all qualified candidates, regardless of characteristics.
We offer reasonable adjustments/accommodations to help all candidates to perform at their best.
If you have a need for any adjustments/accommodations, please complete the section in the application form.